- **RAPT Therapeutics** announced on **September 29, 2025**, that the U.S. Food and Drug Administration (FDA) has **cleared its Investigational New Drug (IND) Application** to proceed to a **Phase 2b clinical trial of RPT904** for the treatment of patients with **food allergy**.  **[1673772_3ca73bee12fd4b939fbe1a3c4d851213_0]** 
- The planned **Phase 2b trial**, named **"prestIgE"**, is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of **RPT904** dosed **every 8 weeks (Q8W)** and **every 12 weeks (Q12W)**.  **[1673772_3ca73bee12fd4b939fbe1a3c4d851213_0]** 
- The company is **on track to initiate this Phase 2b clinical trial by the end of the year**.  **[1673772_3ca73bee12fd4b939fbe1a3c4d851213_0]** 
- **RPT904** is a novel, half-life extended anti-IgE monoclonal antibody designed to inhibit human immunoglobulin E (IgE), a key driver of allergic diseases, and has demonstrated extended pharmacokinetics and pharmacodynamic properties compared to omalizumab in early clinical studies.  **[1673772_3ca73bee12fd4b939fbe1a3c4d851213_1]**

RAPT Therapeutics Announces FDA Clearance for RPT904 Phase 2b Trial

- RAPT Therapeutics has in-licensed **RPT-904**, a next-generation anti-IgE antibody, from Gemincare for worldwide rights excluding China, involving a **$35 million upfront payment** and up to **$670 million in milestones**.  **[1673772_2144295_0]** 
- RPT-904 is designed to improve upon omalizumab (Xolair) with improved half-life, aiming for **Q8 or Q12 week dosing** and the ability to treat high IgE, high weight patients in conditions like food allergy and chronic spontaneous urticaria.  **[1673772_2144295_0]** **[1673772_2144295_2]** 
- Gemincare is conducting two Phase 2 studies for RPT-904 in chronic spontaneous urticaria and asthma, with data expected **before the end of the year**.  **[1673772_2144295_3]**  RAPT plans to initiate its own **Phase 2B food allergy study** before year-end, with top-line data anticipated in the **first half of 2027**.  **[1673772_2144295_3]** **[1673772_2144295_5]** 
- The company projects its **cash runway to extend through the first half of 2027**, aligning with the expected top-line readout for the Phase 2 food allergy trial.  **[1673772_2144295_5]**

RAPT Therapeutics Discusses RPT-904 Clinical Progress and Cash Runway

- RAPT Therapeutics' lead asset, **RPT-904**, is a next-generation anti-IgE antibody in Phase 2 development, targeting **food allergy** (a **$40 billion** U.S. market) and **chronic spontaneous urticaria (CSU)** (a **$5 billion** U.S. market).  **[1673772_tx_380796_1]** 
- RPT-904 aims to differentiate from Xolair (omalizumab) by offering **Q8 week or Q12 week dosing** (compared to Xolair's Q2/Q4 week) and potentially treating patients currently ineligible for Xolair, due to improved half-life and affinity while preserving the same epitope.  **[1673772_tx_380796_1]** **[1673772_tx_380796_2]** **[1673772_tx_380796_3]** 
- The company plans to initiate a **Phase 2b study** for RPT-904 in food allergy before the **end of 2025**, with top-line data expected **18 months** after study start.  **[1673772_tx_380796_4]** **[1673772_tx_380796_6]**  For CSU, RAPT is awaiting **Phase 2 data** from its partner GeminCare in the **second half of 2025**, which could enable direct progression to Phase 3 if positive.  **[1673772_tx_380796_4]** **[1673772_tx_380796_5]** 
- RAPT reported **$170 million in cash** at the end of Q2 2025, providing a cash runway through the **second half of 2027**, which covers the Phase 2b food allergy data readout.  **[1673772_tx_380796_7]**

RAPT Therapeutics (RAPT)